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Effect of early initiation of evolocumab and Combination lipid-lowering agent (statin + ezetimibe) on lipid profiles changes in patients with acute coronary Syndrome undergoing percuTAneous coronaRy intervention: a prospective, randomized controlled trial (C-STAR trial)

Effect of early initiation of evolocumab and Combination lipid-lowering agent (statin + ezetimibe) on lipid profiles changes in patients with acute coronary Syndrome undergoing percuTAneous coronaRy intervention: a prospective, randomized controlled trial (C-STAR trial)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0007908
Enrollment
108
Registered
2022-11-17
Start date
2022-12-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : The experimental and control groups consist of patients undergoing stenting for acute coronary syndrome and will be randomized to receive early evolocumab along with statin/ezetimibe use or no

Sponsors

Yonsei University Yongin Severance Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Over 19 years old (2) Patients who agreed to the research protocol and clinical follow-up survey plan, decided to participate in this study voluntarily, and gave written consent to the informed consent form. (3) Patients who underwent percutaneous coronary stenting for acute coronary syndrome

Exclusion criteria

Exclusion criteria: ? Patients who have previously taken statins, ? Patients with active liver disease or patients with three times or more increase in AST or ALT ? If you have an allergic or hypersensitivity reaction to Evorucumab, statin, or Ezetimib, ? Pregnant women, lactating women, or women of childbearing age who plan to become pregnant during this study ? The remaining life expectancy is expected to be less than a year. ? Subjects who visited the hospital due to psychogenic shock and are expected to be less likely to survive by medical judgment ? Subjects participating in a randomized clinical trial of medical devices/pharmaceuticals

Design outcomes

Primary

MeasureTime frame
Difference in LDL level change after 2 weeks of discharge compared to baseline in test group and control group

Secondary

MeasureTime frame
Percent change in LDL level;Presence or absence of side effects (muscle pain, digestive disturbance, test abnormalities);LFT, CK, HbA1c level

Countries

Korea, Republic of

Contacts

Public ContactYONGCHEOL KIM

Yonsei University Yongin Severance Hospital

yongcheol@yuhs.ac+82-31-5189-8967

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026